A Study With RO5095932 in Patients With Type 2 Diabetes on Stable Metformin Therapy.

Diabetes Mellitus Type 2 Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled, Titration Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose and Escalating Doses of RO5095932 in Patients With Type 2 Diabetes Mellitus on Stable Background Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01017302
• Other study ID #: NP22709
• Status: Completed
• Phase: Phase 1
• First received: November 19, 2009
• Last updated: November 1, 2016
• Start date: December 2009
• Est. completion date: August 2011

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO5095932 in adult patients with type 2 diabetes mellitus. Patients that are on stable metformin therapy are eligible to enter the study. There will be a 5-weeks exenatide run in period and a 5-weeks period when co-administered with the study drug. RO5095932 will be administered subcutaneously as a single dose or as escalating doses. Patients will be randomized to receive either active drug or placebo in weeks 1 to 4. Active drug or placebo will be administered once weekly for 4 weeks. Patients who received active drug in weeks 1 to 4 will receive placebo in week 5. Patients who received a single dose of placebo in weeks 1 to 4, will receive a single dose of active drug in week 5. The anticipated time of study treatment is <6 months. The target sample size is <100 patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Adult patients, 18-65 years of age

• Diabetes mellitus, type 2 for at least 6 months before screening

• On treatment with stable doses of metformin for at least 3 months before screening

• BMI between >/=25 and </=39

Exclusion Criteria:

• Type 1 diabetes

• Pancreatitis

• Treatment with insulin for more than one week within 3 months prior to study start

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Placebo
Subcutenaous once weekly for 4 weeks
• Placebo
Single subcutaneous dose in week 5
• RO5095932
Escalating subcutaneous doses once weekly over a 4 weeks period
• RO5095932
Single subcutenaous dose in week 5

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability of various doses of RO5095932		Weeks 1-4, 6, 8	No
Secondary	Safety and Tolerability of a single dose of RO5095932		Week 5, 6, 8	No
Secondary	Pharmacokinetics: blood concentration		Weeks 1-4, 6, 8	No
Secondary	Pharmacodynamics: glucose, insulin, C-peptide		Weeks 1-4, 6, 8	No